Efficacy and safety of low‐dose atorvastatin plus ezetimibe for primary hypercholesterolemia: A randomized, double‐blind, multicenter phase 3 trial
Studies have suggested that low-dose statin monotherapy may be insufficient for target LDL-C levels. In this randomized, double-blind, multicenter phase 3 trial, we evaluated the efficacy of combined ezetimibe and low-dose atorvastatin in 222 Korean patients with primary hypercholesterolemia. Participants received either 10-mg ezetimibe/5-mg atorvastatin (EZE10/ATV5), 10-mg ezetimibe (EZE10), 5-mg atorvastatin (ATV5), or 10-mg atorvastatin (ATV10). At 8 weeks, EZE10/ATV5 achieved the greatest LDL-C reduction (-44.8%) compared with EZE10 (-12.7%, p < 0.0001), ATV5 (-27.3%, p < 0.0001), and ATV10 (-32.0%, p = 0.0012). The combination therapy showed the highest LDL-C goal achievement rate (41.1% vs. EZE10 8.9%, p < 0.0001; ATV5 10.9%, p < 0.0001; ATV10 27.3%, p = 0.0342), particularly in moderate to high-risk patients. Additionally, EZE10/ATV5 had the lowest adverse events among all groups (6.9% vs. 15.0%, 12.3%, and 27.6%, p = 0.017), with most events being mild. These findings suggest that the combination of ezetimibe and low-dose atorvastatin provides superior lipid-lowering efficacy with an improved safety profile, offering an effective treatment for primary hypercholesterolemia in Korean patients.
Authors
- Jung Hyun Choi (ORCID: https://orcid.org/0000-0001-7171-8843)
- Sung Uk Kwon (ORCID: https://orcid.org/0000-0003-3435-3819)
- Jin‐Man Cho
- Tae‐Ho Park (ORCID: https://orcid.org/0000-0002-9968-8276)
- Hyuck‐Jun Yoon (ORCID: https://orcid.org/0000-0002-0563-7014)
- Seok‐Yeon Kim
- Hong‐Seok Lim (ORCID: https://orcid.org/0000-0002-3127-2071)
- Kyounghoon Lee
- Sanghoon Shin
- Jung‐Won Suh (ORCID: https://orcid.org/0000-0002-0397-6071)
- Jong‐Seon Park (ORCID: https://orcid.org/0000-0001-5242-2756)
- Deok‐Kyu Cho (ORCID: https://orcid.org/0000-0001-6130-3994)
- Sang Rok Lee (ORCID: https://orcid.org/0000-0002-5845-2232)
- Dae‐Hyeok Kim
- Sung Gyun Ahn (ORCID: https://orcid.org/0000-0002-1528-2739)
- Seung‐Whan Lee (ORCID: https://orcid.org/0000-0002-2662-5952)
- Gyung‐Min Park (ORCID: https://orcid.org/0000-0001-5846-0606)
- Jung‐Hoon Sung (ORCID: https://orcid.org/0000-0003-3515-5283)
- Hwan‐Cheol Park
- Tae Oh Kim (ORCID: https://orcid.org/0000-0002-7275-9302)
Institutions
- Ulsan College (KR)
- Ewha Womans University (KR)
- Yonsei University (KR)
- Severance Hospital (KR)
- Asan Medical Center (KR)
- Seoul National University Bundang Hospital (KR)
- University of Ulsan (KR)
- Seoul Medical Center (KR)
- Gachon University Gil Medical Center (KR)
- Wonju Severance Christian Hospital (KR)
- Inje University Ilsan Paik Hospital (KR)
- Pusan National University Hospital (KR)
- Hanyang University Guri Hospital (KR)
- Jeonbuk National University Hospital (KR)
- CHA University Bundang Medical Center (KR)
- Ulsan University Hospital (KR)
- CHA University (KR)
- Yeungnam University Medical Center (KR)
- Kyung Hee University Hospital at Gangdong (KR)
- Inha University Hospital (KR)
- Dong-A University (KR)
- Keimyung University (KR)
- Ajou University (KR)
Publication Details
- Journal
- Lipids
- Published
- 2025-04-18
- DOI
- https://doi.org/10.1002/lipd.12442
- Primary Topic
- Lipoproteins and Cardiovascular Health
- Type
- article
- Field-Weighted Citation Impact
- 0.00